IASO-782 in Autoimmune Hematological Diseases

ConditionsAutoimmune Thrombocytopenia Warm Autoimmune Haemolytic Anaemia

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorShanghai IASO Biotechnology Co., Ltd

About this trial

This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years

Clinically confirmed diagnosis of autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA)

Failure or relapse after at least 1 treatment for the study disease

Stable dose of immunosuppressants for 4 weeks before screening

Disqualifiers

History of other primary malignant neoplasm within 5 years of screening

Secondary to other disease-induced hematopoietic destruction

Cardiac disorder within the last 3 months

Patients with high blood pressure that cannot be controlled by drug

Trial design

Design model

Parallel

Treatments tested in this trial

IASO-782 injection
Drug
Each subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
placebo
Drug
Each subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).

Treatment groups

16 Participants

are divided into 2 treatment groups

Group A: Experimental groupExperimental treatment 1 intervention

Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants with adverse events as assessed by CTCAE v5.0

The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.

Time frame

up to 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai IASO Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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